Recall Z-0480-2019— GE Healthcare, LLC

Name: FDA recall Z-0480-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-25

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2018-09-25, terminated 2020-07-13. It names one FDA 510(k) clearance: K152809. Product: Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1. Reason: Potential electric leakage affecting the user..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-09-25
Terminated: 2020-07-13
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K152809 — Giraffe Incubator Carestation CS1Ohmeda Medical, A Division of Datex-Ohmeda, Inc.·cleared 2015-12-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1

Reason for recall

Potential electric leakage affecting the user.

Data sourced from openFDA. This site is unofficial and independent of the FDA.